Table 1.
Baseline Characteristics and Baseline OHQ Scoresa
| Variable | Pooled Studies | |
|---|---|---|
| Droxidopa | Placebo | |
| Baseline characteristics | ||
| N | 225 | 235 |
| Male sex, n (%) | 132 (58.7) | 142 (60.4) |
| White race, n (%) | 220 (97.8) | 221 (94.0) |
| Mean ± SD age, y | 65.0 ± 14.7 | 65.4 ± 14.6 |
| Primary clinical diagnosis, n (%) | ||
| Parkinson disease | 150 (66.7) | 157 (66.8) |
| Pure autonomic failure | 34 (15.1) | 38 (16.2) |
| Multiple system atrophy | 31 (13.8) | 25 (10.6) |
| Nondiabetic autonomic neuropathy | 4 (1.8) | 9 (3.8) |
| Dopamine ß-hydroxylase deficiency | 0 | 1 (0.4) |
| Other | 6 (2.7) | 5 (2.1) |
| Baseline OHQ scores | ||
| Mean ± SD OHQ composite score (n) | 5.9 ± 1.7 (224) | 5.8 ± 1.9 (232) |
| Mean ± SD OHSA scores, n | 225 | 235 |
| Item 1 | 6.0 ± 2.2 | 5.8 ± 2.4 |
| Item 2 | 4.3 ± 2.9 | 3.7 ± 2.9 |
| Item 3 | 5.8 ± 2.5 | 5.6 ± 2.7 |
| Item 4 | 5.9 ± 2.4 | 5.9 ± 2.6 |
| Item 5 | 4.6 ± 2.7 | 4.7 ± 2.8 |
| Item 6 | 4.0 ± 3.2 | 4.4 ± 3.3 |
| Composite score | 5.6 ± 1.7 | 5.5 ± 1.8 |
| Mean ± SD OHDAS scores (n) | ||
| Item 1 | 5.1 ± 2.8 (223) | 5.3 ± 2.8 (230) |
| Item 2 | 7.0 ± 2.4 (214) | 6.9 ± 2.8 (229) |
| Item 3 | 4.9 ± 2.9 (223) | 4.7 ± 2.9 (228) |
| Item 4 | 6.7 ± 2.8 (211) | 6.6 ± 3.0 (223) |
| Composite score | 6.2 ± 2.0 (224) | 6.1 ± 2.3 (231) |
OHDAS Orthostatic Hypotension Daily Activity Scale, OHQ Orthostatic Hypotension Questionnaire, OHSA Orthostatic Hypotension Symptom Assessment
aOne patient was randomized to receive droxidopa but was erroneously administered placebo in Study NOH301; this patient was placed among placebo recipients for baseline characteristics and for safety assessments, and among droxidopa recipients for efficacy analyses.